Taiwan FDA registration 9fbf92fe6adc3ee9b35e13dffcb2e623
"Sudi" pylori antibody rapid test reagent (unsterilized)
TW: “速帝”幽門桿菌抗體快速檢驗試劑(未滅菌)
Taiwan·Risk Class 1·STANDARD DIAGNOSTICS, INC.·Registered Aug 12, 2010 – Aug 12, 2015CancelledRegistration details
- Analysis ID
- 9fbf92fe6adc3ee9b35e13dffcb2e623
- Customs Code
- DHA04400908902
Company information
- Manufacturer
- STANDARD DIAGNOSTICS, INC.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Ariel Health Inc
Product details
- Intended Use
- Limited to the first level identification range of the Measures for the Administration of Medical Devices "Helicobacter Serological Reagent (C.0003)".
- Product Type (Level 1)
- C Immunology and microbiology
- Product Type (Level 2)
- C.0003 螺旋桿菌屬血清試劑
- Import Information
- import
Dates and status
- Registration Date
- Aug 12, 2010
- Expiry Date
- Aug 12, 2015
- Cancellation Date
- Apr 25, 2018
Cancellation information
- Status
- Logged out
- Reason
- 自行鍵入
About this record
Access comprehensive regulatory information for "Sudi" pylori antibody rapid test reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 9fbf92fe6adc3ee9b35e13dffcb2e623 and manufactured by STANDARD DIAGNOSTICS, INC.. The authorized representative in Taiwan is Ariel Health Inc.
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